Niraparib Combined With Anlotinib in Homologous Recombination Repair (HRR) Gene-mutated Advanced Solid Tumors

Inclusion Criteria

• •Subjects understand the trial process, sign informed consent, agree to participate in the study, and have the ability to follow the protocol;
• •18 \~ 70 years old
• •HER2 negative breast cancer, cholangiocarcinoma, gastric adenocarcinoma and pancreatic cancer confirmed by histology or cytology meet any of the following conditions: first line treatment failure of HER2 negative breast cancer; first line treatment failure of cholangiocarcinoma; second line treatment failure of gastric adenocarcinoma; first line treatment failure of pancreatic cancer
• •At least one measurable target lesion that meet RECIST 1.1 criteria
• •Can provide paraffin-embedded tumor tissue samples or plasma samples for HRR gene detection
• •Carry pathogenic or suspected pathogenic germline or somatic HRR gene mutations, HRR genes include BRCA1, BRCA2, ATM, ATR, BAP1, BRIP1, CHEK2, FANCA, PALB2 and RAD51, mutations in other HRR genes should be evaluated by researchers and the pathogenicity should be supported by published literature or clinical studies.
• •ECOG physical status score is 0-1
• •Life expectancy \> 6 months
• •Good organ function, including: Neutrophil count \>= 1500 / μL; Platelets \>= 100,000 / μL; Hemoglobin \>= 10g / dL; Serum creatinine \<= 1.5 times the upper limit of normal value, or creatinine clearance \>= 60mL / min (calculated according to Cockcroft-Gault formula); Total bilirubin \<= 1.5 times the upper limit of normal value or direct bilirubin \<= 1.0 times the upper limit of normal value; AST and ALT \<= 2.5 times the upper limit of normal value. When liver metastases are present, it must be \<= 5 times the upper limit of normal value
• •The toxic side effects of any previous chemotherapy have recovered to \<= CTCAE level 1 or baseline levels, except for sensory neuropathy or hair loss with stable symptoms \<= CTCAE level 2